BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8651873 · Received May 29, 2019

    Report

    Report Number
    1645337-2019-12671
    Event Type
    Injury
    Date Received
    May 29, 2019
    Report Date
    May 2, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000525
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, A CORRECTION WAS MADE PER CLINICIAN REVIEW: CHEST INJURY CODE WAS REMOVED FROM THE RIGHT BREAST IMPLANT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 9/23/2019, CHEST INJURY CODE WAS ADDED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. THEREFORE, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 5925167, AND NO NON-CONFORMANCE'S RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 450CC MENTOR MEMORYGEL BREAST IMPLANT AND WAS PRESENTED WITH LEFT SIDE BREAST IMPLANT RUPTURE SECONDARY TO FALL TRAUMA. THE PATIENT ALSO HAD GRADE IV CAPSULAR CONTRACTURE ON THE LEFT SIDE, AND CAPSULAR CONTRACTURE; BAKER GRADE III ON THE RIGHT SIDE. AS A RESULT, THE DEVICE WAS EXPLANTED, AND REPLACED WITH CAT# SHPX450; S/N: (B)(4) ON THE LEFT AND CAT# SHPX450; S/N: (B)(4) ON THE RIGHT SIDE ON (B)(6) 2019. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443848 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5925167 00081317000525

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention